Computer System Validation Position.Pay Rate Range : $52 - $60 / hr W2.Strong knowledge of regulatory guidelines and standards related to computer system validation in the pharmaceutical industry (e.E...Show moreLast updated: 9 days ago
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InsideHigherEdJersey City, New Jersey
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Computer System Validation Position
Artech LLCNJ
9 days ago
Salary
$52.00–$60.00 hourly
Job type
Full-time
Job description
Computer System Validation Position
Plainsboro, NJ
Hybrid Position
Pay Rate Range : $52 - $60 / hr W2
Top Skills :
Strong knowledge of regulatory guidelines and standards related to computer system validation in the pharmaceutical industry (e.g., FDA 21 CFR Part 11, GAMP 5).
Experience in validating computerized systems used in pharmaceutical industry.
Knowledge of validation methodologies, risk assessment techniques, and validation documentation practices
Required Skills :
Education requirement, minimum : Bachelor’s degree in computer science, Information Technology, Life Sciences, or a related field
Experience requirement, minimum : minimum of 4 years of direct experience in validation in pharmaceutical, biotechnology, or regulated healthcare industry
Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21CFR Part 11 compliance.
Strong understanding of computerized system validation principles, regulatory requirements, and quality management systems.
Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
Exceptional communication and interpersonal skills, with the capacity to work collaboratively with internal and external stakeholders.
Detail-oriented with a strong analytical mindset and problem-solving capabilities.
Job Description :
In the position of IT Quality Assurance Associate, you will support implementation and operational aspects of IT systems while ensuring compliance with internal and external requirements.
Provide compliance guidance across IT and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.
Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to 21CFR Part 11 Compliance and other relevant regulations.
Review, and approve CSV lifecycle documents, including validation plans, requirements, risk assessments, and validation summary reports.
Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
Review incidents and changes to computer systems for GxP impact, identifying necessary validation or qualification requirements.